WO2006052756A1 - Appareil intra-oral - Google Patents

Appareil intra-oral Download PDF

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Publication number
WO2006052756A1
WO2006052756A1 PCT/US2005/040029 US2005040029W WO2006052756A1 WO 2006052756 A1 WO2006052756 A1 WO 2006052756A1 US 2005040029 W US2005040029 W US 2005040029W WO 2006052756 A1 WO2006052756 A1 WO 2006052756A1
Authority
WO
WIPO (PCT)
Prior art keywords
wearer
mouthpiece
oral device
tube member
tube
Prior art date
Application number
PCT/US2005/040029
Other languages
English (en)
Inventor
Harold E. Cutler
Original Assignee
Cutler Harold E
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cutler Harold E filed Critical Cutler Harold E
Priority to CA002628205A priority Critical patent/CA2628205A1/fr
Priority to US10/593,172 priority patent/US8739794B2/en
Publication of WO2006052756A1 publication Critical patent/WO2006052756A1/fr
Priority to GB0709909A priority patent/GB2434320B/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C5/00—Filling or capping teeth
    • A61C5/90—Oral protectors for use during treatment, e.g. lip or mouth protectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A61F5/566—Intra-oral devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/08—Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices

Definitions

  • the Present Invention relates to an oral device which is worn by a wearer and, more particularly, an oral device worn by a wearer during sleep for the prevention of various "somno-respiratory" conditions (i.e., conditions that affect the breathing of a sleeping individual), including, for example, sleep apnea, also known as airway occlusion, and/or snoring.
  • various "somno-respiratory" conditions i.e., conditions that affect the breathing of a sleeping individual
  • sleep apnea also known as airway occlusion, and/or snoring.
  • sleep apnea generally refers to a condition in which a person, who is initially asleep, stops breathing due to airway blockage, usually as a result of the collapsing of the soft palate. Although sometimes known as “airway occlusion,” the term “apnea” more accurately refers to the actual cessation of breathing. In chronic states, sleep apnea may tend to lead to various physiologic conditions, including, for example, hypoxema, hypercapnia and congestive heart failure.
  • central sleep apnea the rarer of the two, occurs when a problem in the central nervous system (particularly the areas of the brainstem responsible for respiratory drive) interrupts breathing.
  • central sleep apnea is more common at higher elevations.
  • the Present Invention is concerned more with obstructive sleep apnea, and, therefore, the use of the phrase "sleep apnea" will heretofore be used to mean obstructive sleep apnea.
  • sleep apnea is caused by the relaxation of the muscles in a person's airway during sleep. While the vast majority of people successfully maintain a patent (i.e., open) upper airway and breathe normally during sleep, a significant number of individuals are prone to severe narrowing (i.e., occlusion) or collapsing of the pharynx or soft palate, such that breathing is impeded or even completely obstructed.
  • airway muscles are activated which open the airway, allowing breathing to resume, but, in some cases, such as when the muscles cause snoring or a similar reaction, interrupting the person's deep sleep.
  • An "event” can either be an apnea, characterized by the complete cessation of airflow for at least 10 seconds, or a hypopnea, in which airflow decreases by 50 percent for 10 seconds or decreases by 30 percent if there is an associated decrease in the oxygen saturation or an arousal from sleep.
  • the number of events per hour is reported as the Apnea- Hypopnea Index.
  • An Index value of less than 5 is considered normal; 5-15 is mild; 15- 30 is moderate and more than 30 events per hour characterizes severe sleep apnea.
  • recurrent episodes of airway obstruction are associated with asphyxia, hypertension, depression and daytime fatigue, since a transient interruption of the sleep cycle accompanies the restoration of airway patency. Most apnetic individuals are not aware of these events, and are usually informed of the symptoms by their sleep partner.
  • the apneic episodes are thought to account for the clinical sequelae (symptoms that arise from a particular condition), which include increased incidence of chronic hypertension, a 700% rise in road traffic accidents, excessive daytime somnolence (similar, but unrelated to narcolepsy), social and family disruption, and cardiac arrhythmias and morbidity. Obstruction of the upper airway may also be a cause of or may contribute to sudden infant death syndrome.
  • the management of sleep apnea was revolutionized with the introduction of continuous positive airway pressure, 'in which the airway of the apnetic is forced open through the use of a positive stream of air pressure into the lungs of the apnetic.
  • One such method is described in U.S. Patent No.
  • Hart discloses a rigid oral appliance for installation within the mouth of an individual to prevent obstruction of the natural airway of the individual and to enhance natural ventilation during sleep. Hart also discloses an embodiment in which the oral appliance may be used without an external positive air supply.
  • Hart is deficient in a number of aspects that ultimately prove it disadvantageous to solving the problem of managing sleep apnea.
  • Hart describes a mouthpiece member that is rigid in nature and must be molded to the contours and structure of an individual patient.
  • the necessity of requiring dental molds to be taken and a mouthpiece member created by a lab and fitted to the wearer by a physician greatly reduces the effectiveness of treatment on the general population due primarily to excessive cost.
  • the device disclosed in Hart is, by its design, maximally intrusive. It is intended to fill the entire oral cavity of the wearer. As a result, and as with any foreign object which would be inserted into one's oral cavity during sleep, the natural reaction of the body would be to reject or remove the device.
  • the Hart device does not include a retaining strap, which would preferably serve not only to keep the device in place during use, but also to make the device easy to locate and reinsert if it is removed during sleep.
  • a retaining strap which would preferably serve not only to keep the device in place during use, but also to make the device easy to locate and reinsert if it is removed during sleep.
  • the Present Invention overcomes the deficiencies listed above by providing a flexible, easy to wear device which will prevent instances of sleep apnea from occurring. To this end, an oral device is disclosed.
  • the oral device comprises a mouthpiece member, a tube member and an attachment member.
  • the mouthpiece member comprises a resilient material, and is adapted to fit within the contours of the teeth of a wearer.
  • the tube member is affixed, at a first end, to the mouthpiece member, and extends outward from the mouthpiece member towards the soft palate of the mouth of the wearer.
  • the attachment member is attached to the mouthpiece member at at least one location.
  • the tube member defines an opening, which prevents the collapse of the soft palate of the wearer by allowing for the free transfer of air between the wearer and the environment.
  • the oral device comprises a mouthpiece member, a tube member, a palate member and an attachment member.
  • the mouthpiece member comprises a resilient material, and is adapted to fit within the contours of the teeth of a wearer.
  • the tube member is affixed, at a first end, to the mouthpiece member, and extends outward from the mouthpiece member towards the soft palate of the mouth of the wearer.
  • the palate member extends from a second end of the tube member and is curved upwards to maintain contact with the soft palate of the wearer.
  • the second end of the tube member is opposite the first end of the tube member.
  • the attachment member is attached to the mouthpiece member at at least one location.
  • the oral device comprises a mouthpiece member, a tube member, a palate member, a tongue member and an attachment member.
  • the mouthpiece member comprises a resilient material, and is adapted to fit within the contours of the teeth of a wearer.
  • the tube member is affixed, at a first end, to the mouthpiece member, and extends outward from the mouthpiece member towards the soft palate of the mouth of the wearer.
  • the palate member extends from a second end of the tube member and is curved upwards to maintain contact with the soft palate of the wearer.
  • the second end of the tube member is opposite the first end of the tube member.
  • the tongue member extends from the second end of the tube member and is curved downwards to maintain contact with the tongue of the wearer.
  • the attachment member is attached to the mouthpiece member at at least one location.
  • the tube member defines an opening, which prevents the collapse of the soft palate of the wearer by allowing for the free transfer of air between the wearer and the environment.
  • Figure 1 illustrates a top view of one embodiment of an oral device, constructed in accordance with the teachings of the Present Invention
  • Figure 2 illustrates one embodiment of a perspective view of the mouthpiece and tube members of the oral device illustrated in FIG. 1 ;
  • Figure 3 illustrates a side view of the embodiment of the oral device illustrated in FIG. 1;
  • Figure 4 illustrates a perspective view of a second embodiment of an oral device, constructed in accordance with the teachings of the Present Invention
  • Figure 5 illustrates a perspective view of a third embodiment of an oral device, constructed in accordance with the teachings of the Present Invention.
  • oral device 10 as constructed in accordance with one embodiment of the Present Invention, is illustrated.
  • oral device 10 generally comprises mouthpiece member 12, tube member 14 and attachment member 16.
  • mouthpiece member 12 generally comprises mouthpiece member 12, tube member 14 and attachment member 16.
  • attachment member 16 although not illustrated in the Figures, in operation, it is intended that oral device 10 fits within the mouth of a wearer as a treatment for various "somno-respiratory conditions," including, for example, sleep apnea, in which the air passageway in the mouth of the wearer would otherwise become blocked.
  • mouthpiece member 12 of oral device 10 preferably comprises any member which can be temporarily affixed to, or inserted into, the mouth of the wearer.
  • mouthpiece member 12 may take the form of, essentially, a scuba-style mouthpiece. It is important to note that this scuba-style mouthpiece is but one possible variation of mouthpiece member 12.
  • mouthpiece member 12 may comprise any of a currently-known mouthpiece in the public domain, including, for example, sports mouthpieces, medical mouthpieces, etc.
  • mouthpiece member 12 be of a resilient material, including, for example, rubber.
  • any other material is contemplated, including, for example, silicone, vinyl, etc.
  • Any material used should preferably be non-corrosive, because, in use, mouthpiece member 12, as described above, is intended to be temporarily affixed or inserted, such as by gravity or other means, to the mouth of the wearer.
  • mouthpiece member 12 should not be made of a material that would erode the enamel coating of the wearer's teeth, nor should it be made of any material that would cause any harm to the wearer's health.
  • mouthpiece member 12 should comprise a flexible and/or resilient material.
  • mouthpiece member 12 be made of a non-porous material. During wear, mouthpiece member 12 is in constant contact with the saliva present in the mouth of the wearer. To protect the integrity of mouthpiece member 12, and, actually, of all of oral device 10, it is therefore preferable that the material which comprises mouthpiece member 12 of oral device 10 be of a non-porous material. Finally, it is contemplated that mouthpiece member 12 be made of varying sizes, so as to ensure a proper fit by the wearer, based on the size, age and sex.
  • mouthpiece member 12 be adapted to fit particularly to the teeth of the wearer. In this manner, not only will mouthpiece member 12 fit comfortably within the mouth of the wearer, but mouthpiece member 12 will be securely fit within the mouth of the wearer, thus allowing for optimum operation of oral device 10.
  • the process of adapting mouthpiece member 12 to fit particularly to the teeth of the wearer may preferably be by any currently-known means, including, for example, subjecting mouthpiece member 12 to heat until it becomes pliable and then conforming, through pressure, the pliable mouthpiece member 12 to the teeth of the wearer.
  • Mouthpiece member 12 is preferably shaped to define opening 18.
  • opening 18 allows for the transfer of air from outside the mouth of the wearer of oral device 10 into the body of the wearer, and vice versa.
  • the transfer of air is illustrated by Arrows A and B; Arrow A indicating the transfer or air from the outside of the mouth of the wearer into the body of the wearer; while Arrow B represents the opposing direction.
  • tube member 14 is attached to mouthpiece member 12 in such a manner as to extend opening 18 of mouthpiece member 12 into the mouth of the wearer. That is, tube member 14 is attached to mouthpiece member 12 such that air, from the outside of the mouth of the wearer, passes through opening 18 of mouthpiece member 12 and enters inside portion 20 of tube member 14.
  • tube member 14 is intended to provide a contiguous and open airway from the mouth of the wearer of oral device 10 through to the throat. This purpose is realized by first allowing air to enter the mouth of the wearer through opening 18 of mouthpiece member 12 and through inside portion 20 of tube member 14. Secondly, this purpose is realized by the ability of tube member 14 to force the soft palate of the wearer to remain open during sleep (the collapsing of which, as described above, is symptomatic of sleep apnea).
  • tube member 14 is comprised of a material sufficient in strength to maintain the openness of the wearer's soft palate, while also maintaining a sufficient degree of light weight so as to not burden the wearer. Additionally, similar to mouthpiece member 12, tube member 14 should also realize the characteristics of mouthpiece portion 12; that being a non-corrosive, non-porous, non-eroding, flexible and resilient material.
  • One preferred material is vinyl, although various other materials, including, for example, polyethylene, rubber, plastic, etc. are contemplated.
  • tube member 14 be adjustable. In this manner, tube member 14 can be adjusted to fit any size throat, whether the size is long or short, and, conversely, tube member 14 may be adjusted to provide a proper fit against the soft palate of the wearer.
  • the means for adjusting tube member 14 may be by any currently-known means of adjustment, including, for example, via threading means, via a snap-fit arrangement, etc.
  • FIG. 2 illustrates one embodiment for adjusting tube member 14. Referring to
  • tube member 14 is illustrated as comprising securing member 22, first adjustable member 24, adjusting member 26 and second adjustable member 28.
  • First adjustable member 24 preferably comprises a tube-like shape that fits within or around securing member 22 at one end 30 of first adjustable member 24. At the other end 32 of first adjustable member 24 is disposed adjusting member 26, which bridges the interface between first adjustable member 24 and second adjustable member 28. It is adjusting member 26 that is positioned in such a manner so as to compensate for a longer or shorter throat.
  • adjusting member 26 preferably possesses a plurality of ridges 34, upon which first adjustable member 24 and second adjustable member 28 are affixed.
  • Each of the plurality of ridges 34 when in use, serves to maintain the positioning of first adjustable member 24 and second adjustable member 28 vis-a-vis adjusting member 26.
  • a plurality of securing devices 36 are used to maintain the proper desired length of tube member 14. Therefore, during use, a wearer may adjust tube member 14 to a desired length by extending or contracting first adjustable member 24 and second adjustable member 23. Upon reaching the desired length, the wearer then uses securing devices 36 to maintain the desired length of tube member 14.
  • FIG. 3 which illustrates a side view of the embodiment of oral device 10 illustrated in FIG. 1
  • cushion member 40 disposed on end 38 of tube member 14 away from the end attached to mouthpiece member 12
  • Cushion member 40 is preferably affixed to end 38 of tube member 14 to prevent any irritation which may occur from the hardness of the material of tube member 14 as it maintains contact against the soft palate of the wearer.
  • cushion member 40 be comprised of a sponge-like material, such as, for example a small piece of surgical sponge.
  • attachment member 16 is preferably affixed to mouthpiece member 12 at attachment points 42.
  • Attachment member 16 comprises a flexible, resilient material that wraps around the head of the wearer in an effort to further maintain the position of oral device 10 on the wearer during sleep. Although it is preferable that attachment member 16 be made of a material similar to that of mouthpiece member 12, such is not required, and attachment member 16 only needs to be made of a suitable material to permit the wearer to comfortably secure oral device 10 during sleep.
  • palate member 44 is attached to tube member 14, and extends posterially therefrom.
  • palate member 44 is attached to tube member 14 at one end 46 (preferably via attachment plate 48).
  • palate member 44 extends upward into the soft palate of the wearer. This upward extension is accurately shown in FIG. 4, where palate member 44 is shown as curving towards what would be the soft palate of a wearer.
  • palate member 44 is made of a flexible, non-corrosive, non-porous material, such as, for example, plastic, rubber, coated aluminum, etc., and is of sufficient length and shape for opposing end 50 to reside under the soft palate of the wearer.
  • palate member 44 may be bent into shape for a particular wearer.
  • Palate member 44 may also include anchoring mechanism 52, which is represented as a slot disposed within palate member 44.
  • a retainer such as, for example, a screw (not shown), may be inserted through attachment plate 48 and anchoring mechanism 52 to secure the positioning of palate member 44.
  • palate member 44 provides a platform on which the palate of the user can rest when it collapses as the wearer sleeps, thus ensuring greater patency of the airway.
  • palate member 44 should also be sturdy enough to withstand any forces exerted upon it by the soft palate.
  • the second embodiment also includes cushion member 40, preferably affixed to end 50 of palate member 44 to prevent any irritation which may occur from the hardness of the material of palate member 14 as it maintains contact against the soft palate of the wearer.
  • tongue member 54 extends from tube member 14. Tongue member 54 is preferably made of the same material (and possesses the same characteristics) as palate member 44, and is of sufficient length to reach the rear area of the tongue of the wearer. Anterior end 56 of tongue member 54 is curved downward to follow the shape of the back of the tongue. In this embodiment, palate member 44 then provides a platform on which the palate of the user can rest when it collapses as the wearer sleeps, and tongue member 54 holds the tongue of the user down and out of the way, thus ensuring an even greater patency of the airway.
  • the third embodiment also includes cushion member 40, preferably affixed to end 50 of palate member 44 to prevent any irritation which may occur from the hardness of the material of palate member 14 as it maintains contact against the soft palate of the wearer.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Nursing (AREA)
  • Otolaryngology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Emergency Management (AREA)
  • Business, Economics & Management (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Epidemiology (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

Cet appareil intra-oral comprend une pièce buccale, un tube et une fixation. La pièce buccale en matériau résilient est conçue pour s'emboîter dans le contour des dents du porteur. Le tube, fixé par sa première extrémité à la pièce buccale, ressort de la pièce buccale en direction du palais mou. La fixation est solidaire d'au moins un point de la pièce buccale. Enfin, le tube définit une ouverture empêchant l'effondrement du palais mou du porteur en autorisant le transfert libre d'air entre le porteur et son environnement.
PCT/US2005/040029 2004-11-04 2005-11-04 Appareil intra-oral WO2006052756A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA002628205A CA2628205A1 (fr) 2004-11-04 2005-11-04 Appareil intra-oral
US10/593,172 US8739794B2 (en) 2004-11-04 2005-11-04 Oral device
GB0709909A GB2434320B (en) 2004-11-04 2007-05-23 Oral device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US52276304P 2004-11-04 2004-11-04
US60/522,763 2004-11-04

Publications (1)

Publication Number Publication Date
WO2006052756A1 true WO2006052756A1 (fr) 2006-05-18

Family

ID=36336827

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/040029 WO2006052756A1 (fr) 2004-11-04 2005-11-04 Appareil intra-oral

Country Status (4)

Country Link
US (1) US8739794B2 (fr)
CA (1) CA2628205A1 (fr)
GB (1) GB2434320B (fr)
WO (1) WO2006052756A1 (fr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140190490A1 (en) * 2007-11-18 2014-07-10 Dreamscape Medical Llc Integrated oral appliance for sleep-disordered breathing
AU2009298395B2 (en) 2008-10-02 2014-11-20 Lumen Devices Llc A palate retainer with attached nasopharyngeal airway extender for use in the treatment of obstructive sleep apnea
EP2349140B1 (fr) 2008-11-25 2016-06-22 Lumen Devices LLC Dispositif medical pour un patient
WO2012112783A1 (fr) 2011-02-17 2012-08-23 Lumen Devices Llc Appareil et procédés de traitement de l'apnée du sommeil
ITRM20120380A1 (it) * 2012-08-02 2014-02-03 Roberta Ficacci Dispositivo di stimolazione neurofisiologica.
US20140275784A1 (en) * 2013-03-13 2014-09-18 Eileen T. Joyce Conscious sedation airway
US10010313B2 (en) 2015-05-18 2018-07-03 Richard L. Arden Mandibular subluxation device and method
US10258319B2 (en) 2015-05-18 2019-04-16 Richard L. Arden Airway assist device and method
US10342526B2 (en) 2015-07-01 2019-07-09 Richard L. Arden Airway assist device and method
US10772757B1 (en) * 2019-06-18 2020-09-15 Chad Harris Anti-snoring mouth guard
CN112998932A (zh) * 2021-02-23 2021-06-22 河海大学常州校区 一种舌根提拉式可调节止鼾器

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US1592345A (en) * 1915-12-15 1926-07-13 Drager Alexander Bernhard Mouthpiece for respiratory apparatus
US5626128A (en) * 1995-08-31 1997-05-06 University Of South Carolina Endotracheal tube fixation device and method of using the same

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US5174284A (en) * 1991-09-05 1992-12-29 G.I. Supply, Inc. Endoscopic bite block
US5590643A (en) * 1995-01-17 1997-01-07 Flam; Gary H. Mandibular protracting oral intubating airway
US5884625A (en) * 1996-07-09 1999-03-23 Hart; William T. Oral appliance for delivering gas to the retroglossal area
US5915385A (en) * 1997-04-02 1999-06-29 Hakimi; Farhad Snore and stress relieving device
US6820617B2 (en) * 1998-08-13 2004-11-23 Fisher & Paykel Limited Breathing assistance apparatus
US6257238B1 (en) * 2000-05-25 2001-07-10 Nizam M. Meah Bite block for upper gastrointestinal endoscopy with tongue depressor
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US1592345A (en) * 1915-12-15 1926-07-13 Drager Alexander Bernhard Mouthpiece for respiratory apparatus
US5626128A (en) * 1995-08-31 1997-05-06 University Of South Carolina Endotracheal tube fixation device and method of using the same

Also Published As

Publication number Publication date
GB2434320A (en) 2007-07-25
GB2434320B (en) 2010-01-13
CA2628205A1 (fr) 2006-05-18
US8739794B2 (en) 2014-06-03
US20080178888A1 (en) 2008-07-31
GB0709909D0 (en) 2007-07-04

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